Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT04615546

Conditions

Post-Bariatric Hypoglycemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Use of Continuous Glucose Monitor (CGM)

Use of "Cardea Solo" monitoring

Study Details

Brief summary:

Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at the time of hypoglycemia. Severe hypoglycemia can be dangerous and debilitating and can also impact cognitive function. At the moment no medical therapies have been developed for this disorder. Determining why some but not other patients develop this condition would allow for improved prediction, prevention, and treatment approaches. The purpose of the study is to understand the physiological changes observed in those patients who undergo gastric bypass and develop symptomatic hypoglycemia.

Conditions

Post-Bariatric Hypoglycemia

Study ID

NCT04615546

Start date

May 6, 2020

Status verified date

Dec, 2024

Completion date

Jun, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Male or female patients 18-70 years of age
  • Post-bariatric surgery more than 6 months prior to signing the informed consent (not required for non-surgical controls)
  • Documented history of hyperinsulinemic hypoglycemia (not required for post-bariatric and non-surgical controls)

Exclusion Criteria:

  • Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.
  • Participation in any clinical investigation within 4 weeks prior to dosing
  • History of or current insulinoma
  • Active infection or significant acute illness within 2 weeks prior to dosing
  • Female patients who are pregnant or lactating
  • Women of childbearing potential and not utilizing effective contraceptive methods
  • Inadequate end organ function as defined by: Serum creatinine >2.0 mg/dL, alanine transaminase (ALT) and aspartate aminotransferase (AST) > 2 x Upper Normal Limit
  • Allergy to test meal or medications used in the study

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Remote Phase: Post-Bariatric Hypoglycemia Patients

Participants will wear continuous glucose monitor (CGM) in a blinded manner (cannot see data output) for 20 days followed by in an unblinded manner (can see data output) for 20 days.

no intervention: In-Clinic Phase: Post-Bariatric Hypoglycemia Patients

Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions. This group will also wear CGM during a portion of the metabolic tests. This may include participants from the Remote Phase or newly enrolled participants.

no intervention: In-Clinic Phase: Surgical Controls

Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.

no intervention: In-Clinic Phase: Nonsurgical Controls

Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.

no intervention: In-Clinic Phase: Post-Bariatric Hypoglycemia Patients with indwelling gastrostomy tube

Participants will undergo standardized mixed meal tolerance tests via oral, gastrostomy tube, and concomitant oral + gastrostomy tube routes of delivery with metabolic parameters assessed.

Interventions

Use of Continuous Glucose Monitor (CGM)

Participants will wear CGM

Use of "Cardea Solo" monitoring

Participants will wear a "Cardea Solo" patch during blinded CGM use

Primary outcome measure

  • Steady state plasma glucose (SSPG) as a measure of insulin sensitivity [ Time Frame: Baseline 4-hour SSPG ]
  • Rate of gastric emptying [ Time Frame: Baseline 4-hour scintigraphy procedure ]
  • Concentration of Glucagon-Like peptide 1 secretion augmentation of insulin secretion rate [ Time Frame: Baseline 4-hour graded-glucose infusion ]
  • Rate of clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL) [ Time Frame: 40 days ]
  • Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL) [ Time Frame: 40 days ]
  • Rate of arrhythmia during hypoglycemia [ Time Frame: 10 days ]

Central Contacts and Locations

Locations

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305-5103

Contacts

Colleen Craig, MD

650-724-2474cmcraig@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Dec 4, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-12-04.